A well-known medical fact is that muscle compensation patterns can be used to differentiate chronic versus acute injuries. Acute injuries are typically exemplified by muscle spasm and hyperactivity. Chronic injuries are typically associated with compensation, bilateral changes, and absence of a reflection relaxation response. It is also a proven fact that many physicians deal with complaints and injuries that derive from soft tissue injury, particularly the cervical, thoracic, lumbosacral and extremities. All muscle groups of the body, from the cervical including the scalene muscles, mid-thoracic, lumbosacral and extremities can be monitored using the applicant's Electro Diagnostic Functional Assessment Unit (EFA-2) for both humans and animals. This is extremely beneficial because most soft tissue injuries may be chronic or acute with no physical indicators. Direct palpitation of soft tissues injuries can, in some cases, reveal the nature or type of injuries but this manner of diagnosis relies on static testing. This manner of diagnosis also relies on individual tests that are performed separately, which are less reliable than combining and integrating the evaluations of Electromyography (EMG), range of motion, functional assessment, cardiac response, temperature and nerve conduction. The combinations of these tests, unlike any other test, do not rely on the coefficients of variance but measure muscle activity while simultaneously monitoring range of motion, functional assessment, grip strength, pinch strength, cardiac response, temperature and nerve conduction velocity. This dynamic integration provides an analysis of Type 1 versus Type 11 motor units, which coordinate with effort produced by the individuals. Furthermore, when disc pathology is present there is a chemical released in the blood supply which causes ischemic changes in the surrounding musculature. The benefit of quantifying the above conditions in a non-invasive and portable manner is that the amount of ischemia/vasoconstriction in the surrounding blood tissue correlates with the degree of disc pathology, thereby allowing treatment recommendations to be made, i.e., surgery versus physical therapy. The benefit of the EFA-2 is its ability to monitor and site-specifically treat various muscles or muscle groups.
In the past range of motion testing was often relied upon to determine the cause of muscle activity, however prior range of motion testing was done in two planes. The EFA-2 is able to perform testing in six planes of spinal and extremity range of motion, which captures an individual's and/or animal's complete range of motion and integrates it with electro diagnostic EMG activity. This provides pertinent information on structural as well as muscle function and relates to the nature of soft tissue injuries.
The Mayo Clinic confirmed studies on sagittal gait patterns and knee joint functions that static measurements do not correlate well with true functional assessment of movement. As part of the Mayo Clinic conclusions, they recommended the use of functional assessment as a routine diagnostic tool in a similar manner as an electro cardiogram (EKG). In this setting the use of tests such as a MRI or X-RAY are of little use since they are static tests and not specifically designed to evaluate soft tissue damage and subsequent change in function. Therefore, there is a growing need within the medical, veterinary, insurance and industrial communities for objective analysis of biomechanics on a functional level.
Myofascial injuries represent a significant medical problem, with back pain accounting for a large number of medical visits. In the United States alone 60 billion dollars a year is spent on soft tissue injuries related to worker's compensation claims and 20 billion dollars is spent on repetitive stress injuries such as Carpal Tunnel Syndrome (CTS). These injuries account for the most lost days and are currently two of the most costly health problems. The cost of these problems is expected to increase, especially with Occupational Safety and Health Administration (OSHA) considering a new ergonomic standard for repetitive stress injuries. With the implementation of the American's with Disability Act (ADA), worker's compensation claims such as CTS have increased and are expected to exceed 40 billion dollars within the next five years. These excessive claims can damage the economy and force employers to go outside of the United States. A recent study revealed that over forty-five percent of individuals who have undergone CTS relief surgery have experienced no improvement two years after the surgical intervention because they were misdiagnosed. The muscles in the anterior and posterior cervical area can cause pain and mimic symptoms of carpal tunnel syndrome, ulnar neuropathy, cubital tunnel, tendonitis, DeQuarian's syndrome and thoracic outlet syndrome. In addition, soft tissue injuries in large animals such as horses are quite prevalent and costly.
The problem is that until the development of the instant invention there was no way to ascertain if an injury was proximal, cervical or distal. Sixty-five percent of individuals who have undergone back surgery resulted in failed back syndrome or with no relief of symptomatology when the problem was myofascial or soft tissue in nature. There was no way to ascertain the extent of the myofascial pathology until the advent of the EFA-2.
The EFA-2 solves many of the above problems by enhancing, integrating and combining EMG activity to measure muscle function, range of motion testing in at least six planes for the spine and extremities, cardiac monitoring, nerve conduction studies and temperature. The EFA-2 combines up to 100 channels of proprietary surface EMG, up to 24 range of motion channels, at least 2 functional capacity evaluation sensor(s) such as those used to measure grip and pinch strength, 6 sensor(s) for cardiac monitoring, up to 4 sensor(s) for brain monitoring (EEG), a temperature sensor(s), 4 sensor(s) for nerve conduction velocity study, a blood flow sensor(s) and a heart rate sensor(s), plus electrical stimulation sensor(s) and ultrasound sensor(s) for treatment. The nerve conduction velocity (NCV) also has its own temperature sensing and preset sensor(s). In addition, the NCV can be used to deliver electrical stimulation for treatment. The EFA-2 can be battery operated and can perform remote monitoring.
A search of the prior art did not disclose literature or patents that read directly on the claims of the instant invention. However, the following U.S. patents are considered related.
PAT. NO.INVENTORISSUED6,678,549Cusimano, et al13 Jan. 20045,513,657Cusimano, et al7 May 19965,462,065Cusimano, et al31 Oct. 19955,042,505Mayer, et al27 Aug. 19914,688,581Moss25 Aug. 19874,667,513Konno26 May 1987
The U.S. Pat. Nos. 5,513,651 and 5,462,065 patents disclose an integrated movement analyzing system that utilizes surface EMG in combination with range of motion and functional capacity testing to monitor muscle groups in the human body. The system consists of an integrated movement analyzer (IMA) that receives inputs from surface EMG sensor(s), a range of motion (ROM) and a functional capacity sensor(s). When performing upper and lower back testing, the ROM is connected between a patient's upper back and lower back by a shoulder harness and a waist belt. For cervical testing, the ROM is connected between the patient's head and upper back by a cervical cap and the shoulder harness. The output of the IMA is provided via an analog to digital converter to a computer. The computer, in combination with a software program, produces an output consisting of comparative analytical data. This data is taken via a parallel port and multiple a/d cards while the patient is not isolated. The unit is not integrated and cumbersome.
The U.S. Pat. No. 5,042,505 patent discloses an electronic device for measuring relative angular positional displacement and angular range of motion for body segments and articulating joints of the human skeleton. The device has a hand-held interface unit, which is placed against the body segment or joint to be tested. Mounted within the housing of the interface unit is a shaft with a pendulum at one end and an optical encoder at the other. As the body segment rotates or the joint articulates, the pendulum swings in the direction of gravity, causing the shaft to rotate. The optical encoder generates an electrical signal representative of the amount of rotation of the shaft. The generated signal is fed to a microscope which processes the information and can produce or display the change in angular position relative to initial angular position or the angular range of motion of the body segment or articulating joint.
The U.S. Pat. No. 4,688,581 patent discloses an apparatus and a method for non-invasive in-vivo determination of muscle fiber composition. The method includes the steps of electrically stimulating a chosen muscle, determining the stimulation current; measuring the electrical potential of the muscle, the contraction time and the force produced by the contraction and by intercorrelating the data by multiple regression, thereby determining the type, percentage and size of the muscle fibers within the muscle stimulated. The apparatus for determining the muscle composition includes a muscle stimulator of controlled voltage electromygram equipment and a force transducer, thus providing a tension curve as well as force measurements.
The U.S. Pat. No. 4,667,513 patent discloses an apparatus and a method for estimating the degree of fatigue and pain of muscles. The apparatus composes subjects of different weights on the same basis by deriving variations in the muscular strength such as dorsal muscular strength, shoulder muscular strength, grasping power and the like. An analogous electric signal integrates the muscular output on one hand, and provides an integrated value of the electromyogrammatic amplitude by processing the voltage induced from the muscle to be tested through an electromygram amplitude and waveform processor. The ratio between these integrated values after correlating the ratio with the weight/muscular strength coefficient is digitally displayed.
The U.S. Pat. No. 6,678,549 patent discloses a system that combines EMG, ROM and NCV. The system does not allow remote monitoring, blood flow monitoring or different ROM. The system uses an interface that does not allow for the rapid exchange of data, uses multiple data acquisition cards that do not have data consistency and is not an integrated unit, thereby making it cumbersome and less reliable. It is also only for humans, not animals.
For background purposes and as indicative of the art to which the invention relates, reference may be made to the following remaining patents found in the search.
PAT. NO.INVENTORISSUED5,056,530Butler, et al15 Oct. 19915,050,618Larsen24 Sep. 19915,042,505Meyer, et al27 Aug. 19915,038,795Roush, et al13 Aug. 19915,012,820Meyer7 May 19914,938,476Bryunnell, et al3 Jul. 19904,928,709Allison, et al29 Jul. 19904,886,073Dillion, et al12 Dec. 19894,845,987Kenneth11 Jul. 19894,834,057McLeod, Jr.30 May 19894,805,636Barry, et al21 Feb. 19894,800,897Nilsson31 Jan. 19894,742,832Kauffmann, et al10 May 19884,667,513Konno26 May 19874,586,515Berger6 May 1986
The EFA-2 performs all the physiological monitoring, i.e., muscles nerves, brain waves, cardiac, blood flow, heart rate, range of motion and functional capacities into one invention. In addition, the EFA-2 offers therapeutic capabilities. None of the other systems offer therapeutic intervention and complete physiological monitoring. Also, the EFA-2 offers remote monitoring.